US7942897B2 - System for closing an opening in a body cavity - Google Patents

System for closing an opening in a body cavity Download PDF

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Publication number
US7942897B2
US7942897B2 US10/616,622 US61662203A US7942897B2 US 7942897 B2 US7942897 B2 US 7942897B2 US 61662203 A US61662203 A US 61662203A US 7942897 B2 US7942897 B2 US 7942897B2
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United States
Prior art keywords
backing
closure
hooks
closure device
distal end
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related, expires
Application number
US10/616,622
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English (en)
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US20050010248A1 (en
Inventor
Daniel M. Lafontaine
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Boston Scientific Scimed Inc
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Boston Scientific Scimed Inc
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Priority to US10/616,622 priority Critical patent/US7942897B2/en
Assigned to SCIMED LIFE SYSTEMS, INC. reassignment SCIMED LIFE SYSTEMS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LAFONTAINE, DANIEL M.
Priority to PCT/US2004/021972 priority patent/WO2005006989A2/fr
Publication of US20050010248A1 publication Critical patent/US20050010248A1/en
Assigned to BOSTON SCIENTIFIC SCIMED, INC. reassignment BOSTON SCIENTIFIC SCIMED, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SCIMED LIFE SYSTEMS, INC.
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00659—Type of implements located only on one side of the opening

Definitions

  • the present invention relates to closing openings in a vessel or other body cavity. More specifically, the present invention relates to a closure device that quickly closes openings in body tissue by engaging the adventitia closely adjacent the wall of the vessel or body cavity.
  • Another problem associated with closing punctures in blood vessels is that during insertion and removal of various devices into the lumen of the blood vessel, the position of the vessel relative to the surface of the skin can change. Therefore, determining the exact position of the outer wall of the blood vessel can be difficult.
  • the vessel when entry is gained into the lumen of the blood vessel by puncturing the blood vessel, the vessel may not have been punctured in a direction entirely orthogonal to the longitudinal axis of the blood vessel. Instead, the blood vessel may be punctured in a “side stick” fashion in which case the puncture is made in an off-center position. In such punctures, it is difficult to locate the outer wall of the blood vessel as well.
  • a closure device closes an opening in a body cavity.
  • the closure device includes an elongate delivery member and a closure component which is removably connected to the distal end of the delivery member.
  • the closure component has a collapsible backing movable between a non-collapsed position and a collapsed position.
  • the closure component also includes a plurality of fibrous tissue engaging members disposed on the backing and oriented in a non-engaging orientation when traveling in a distal direction and in an engaging orientation when traveling in a proximal direction. The fibrous tissue engaging members become entangled in the backing when the backing is in the collapsed position.
  • the present invention can also include a method of closing an opening in a body.
  • the method includes inserting distally through the opening a closure component having a collapsible pile backing with pile engaging hooks and tissue engaging hooks disposed thereon.
  • the method further includes withdrawing the closure component proximally relative to the opening such that the tissue engaging hooks engage tissue adjacent the opening.
  • the collapsible pile is then collapsed so that the pile engaging hooks engage portions of the pile backing.
  • FIG. 1 is a side view of an opening in a blood vessel.
  • FIG. 2 is a side view of a portion of a closure device in accordance with one embodiment of the present invention.
  • FIG. 3 illustrates the closure device shown in FIG. 2 inserted into the blood vessel shown in FIG. 1 .
  • FIG. 4 illustrates partial closure of the opening in the blood vessel.
  • FIG. 5 illustrates a closure device in a fully collapsed position.
  • FIG. 6 is an end view of the closure device shown in FIG. 5 .
  • FIGS. 7A and 7B are side views of other embodiments of closure devices in accordance with the present invention.
  • FIG. 8 is a side view of another embodiment of a closure device in accordance with the present invention.
  • FIG. 9 is an end view of the closure device shown in FIG. 8 in a fully clasped position.
  • FIG. 10 is a side view of one embodiment of an actuable locking mechanism for locking a closure device on the distal end of an elongate member in accordance with one embodiment of the present invention.
  • FIG. 1 is a side view of a portion of a blood vessel 10 . While the present invention can be used with substantially any body cavity, a blood vessel is described herein for exemplary purposes only.
  • Blood vessel 10 has a lumen 12 defined by a blood vessel wall 14 .
  • Blood vessel wall 14 is shown as having an opening 16 therein. Opening 16 can be an opening which was made, for example, in order to perform a treatment procedure during which access to lumen 12 is needed.
  • Vessel wall 14 is formed of media having an endothelial inner layer which is generally smooth muscular tissue.
  • the media is surrounded by adventitia 18 .
  • the adventitia 18 includes fibrous collagen.
  • FIG. 2 is a side view of a portion of a closure device 20 in accordance with one embodiment of the present invention.
  • Closure device 20 includes an elongate member 22 which can be, for example, a catheter or wire having an inner lumen for receiving an optional wire 24 .
  • Elongate member 22 has a proximal end which is manipulable by the physician, and a distal end 26 which has closure member 28 mounted thereon.
  • Optional wire 24 is illustratively formed as a guide wire or core wire with a resilient hook 30 disposed at the distal end thereof.
  • hook 30 is described in greater detail below.
  • closure member 28 includes a generally cone-shaped pile backing 34 with a plurality of hook members 36 disposed thereon.
  • the hooks 36 and pile 34 are formed from hook and loop fabric such as that sold under the commercial designation “VELCRO” or other similar material.
  • closure member 28 is formed of hook and loop fabric, it is similar to conventional hook and loop fabric except that the hooks 36 of the hook and loop fabric are mounted on the loop or pile portion of the hook and loop fabric which forms backing 34 . Therefore, if closure member 28 were to be compressed upon itself, it would stay in the compressed shape because the hooks 36 would engage the underlying loops which form backing 34 .
  • FIGS. 3-6 illustrate the operation of closure device 20 in accordance with one embodiment of the present invention, in which opening 16 in blood vessel 10 is closed using the device.
  • FIG. 3 shows that an introducer sheath 38 has been introduced into opening 16 in blood vessel 10 .
  • Closure device 20 has been inserted through introducer sheath 38 into lumen 12 . It should be noted, of course, that closure device 20 can be preloaded into the introducer sheath 38 before the introducer sheath is inserted into opening 16 . Also, however, if introducer sheath 38 is already in place in the vessel 10 from some prior procedure, closure device 20 can simply be inserted through introducer sheath 38 after other devices have been removed therefrom.
  • hooks 26 are radially expanded and oriented such that, as they are advanced distally through the introducer sheath 38 , they are in a non-engaging, or sliding, orientation. Hooks 36 may optionally be slightly collapsed toward the longitudinal central axis of the introducer sheath 38 as well, as they travel through the introducer sheath 38 .
  • hooks 36 are oriented on backing 34 such that they are in an engaging or hooking orientation as they move proximally.
  • introducer sheath 38 is removed from opening 16 in blood vessel 10 by withdrawing it proximally. When that happens, the vessel wall 14 defining opening 16 contracts around elongate member 22 .
  • FIG. 4 shows closure device 26 in a position in which closure of opening 16 has begun. After introducer sheath 38 has been withdrawn proximally, elongate member 22 and wire 24 are also withdrawn proximally through opening 16 . Hooks 36 travel through the media layer which forms vessel wall 14 , without becoming tangled in that tissue, because it is rather smooth muscle tissue.
  • hook 30 on the distal end of wire 24 engages the distal tip of the backing material 34 and generally pulls the cone shaped backing material proximally with it in a direction indicated by arrows 40 .
  • the backing material is a flexible fabric, it begins to collapse on itself proximally. This exposes portions of the underlying fabric backing 34 to distally located hooks which are collapsing on top of it. Those hooks become firmly entangled in the backing, as is the case with conventional hook and loop fabric.
  • the physician continues to withdraw wire 24 proximally continuing to cause closure member 28 to pile up on itself to form a closure.
  • FIG. 5 shows that closure member 28 has piled upon itself and hooks 36 have engaged exposed portions of pile 34 to form a collapsed, snarled, closure of opening 16 wherein closure member 28 is also firmly entangled and anchored in adventitia 18 .
  • hook 30 deforms to pass through the distal opening in closure member 28 and to thus release closure member 28 .
  • the force required to deform hook 30 can be chosen, as desired, but is illustratively chosen to require a sufficient force to ensure that the closure device 28 has collapsed on itself a sufficient amount so it is fully withdrawn from the lumen 12 of vessel 10 .
  • other disconnection systems can be used as well, such as screw thread, a friction fit, a frangible mechanical connection, another hook and loop connection, or other suitable systems.
  • Proximally directed force is also exerted on elongate member 22 such that it disconnects from closure member 28 .
  • This disconnectable connection between the distal end of elongate member 22 and enclosure member 28 can be any suitable disconnectable connection, such as screw thread, a friction fit, an adhesive which can be disconnected through application of a desired amount of force, a frangible mechanical connection, another hook and loop connection in which a strip of loop fabric is disposed at the distal end of elongate member 22 and internal hooks, internal to closure member 28 , are initially engaged in the loop fabric but are disengaged as elongate member 22 is withdrawn proximally, or any other suitable disconnectable connection.
  • FIG. 6 shows an end view of closure member 28 in the collapsed position, looking at closure member 28 from within the lumen 12 of vessel 10 .
  • the hooks 36 of closure member 28 have engaged the exposed pile of backing 34 .
  • the outer row of hooks 36 has engaged and become entangled in, adventitia 18 , to form a substantially complete closure of opening 16 in the lumen 12 of vessel 10 .
  • FIG. 7A is a side view of another embodiment of a closure device 50 .
  • Closure device 50 is shown attached to elongate member 22 with wire 24 disposed therein.
  • device 50 is formed of a plurality of generally coaxially arranged rings 52 . Rings 52 are progressively smaller the further they are located distally on device 50 .
  • Mounted between rings 52 is a web of material 54 which supports a plurality of hooks 56 .
  • hooks 56 are illustratively formed like the hooks in conventional hook and loop fabric.
  • Rings 52 are structurally arranged such that, as wire 24 is withdrawn proximally, the distal tip of device 50 collapses onto the first distal ring 52 .
  • each of the successive rings 52 collapses. Therefore, as with the first embodiment, device 50 is inserted into the lumen 12 of vessel 10 . Elongate member 22 and wire 24 are then withdrawn proximally until the first proximal ring of hooks 56 engages the adventitia. Wire 24 is then drawn proximally (and elongate member 22 can be withdrawn proximally at this point as well) until each of the rings 52 has collapsed proximally to form a closure of opening 16 in vessel 10 .
  • FIG. 7B illustrates another embodiment similar to that shown in FIG. 7A .
  • FIG. 7B shows a closure device 59 in which elongate member 22 has disposed at its distal end a plurality of rings 60 . Rows of hooks 56 are also mounted to a plurality of rings 62 which are disposed on web material 54 .
  • web of material 54 is formed of a resilient, stretchable material. Rings 60 are formed slightly larger than the spaces between rings 62 . Therefore, as web 54 is stretched over rings 60 , rings 60 protrude outwardly stretching web 54 between rings 62 , thereby holding closure device 59 in place on the distal end of the elongate member 52 .
  • device 59 takes substantially the same shape as that shown in FIG. 7A . However, for withdrawal, no wire 24 is needed. Instead, as elongate device 22 is withdrawn proximally, the first proximally located ring of hooks 56 on device 59 engages the adventitia. As additional proximal force is exerted on elongate member 22 , the first proximal ring 60 becomes dislodged from within web 54 . However, the remaining rings 60 are still frictionally engaged with the web 54 of device 59 .
  • FIGS. 8 and 9 illustrate another embodiment of a closure device 70 in accordance with the present invention.
  • Closure device 70 is again disconnectably connected to elongate member 22 and wire 24 .
  • Device 70 includes a web material 72 and a plurality of hooks 74 . Again, the entire web 72 can be filled with hooks 74 , although they are not shown simply for the sake of clarity.
  • Web 72 is supported by collapsible structural members 76 which are either formed integrally with web 72 or connected thereto by a suitable connection technique.
  • the first row of hooks 74 engages the adventitia and the user proximally withdraws wire 24 . This causes the structural members supporting web 72 to collapse upon themselves, again forming a collapsed generally disc shaped closure such as that shown in FIG. 9 .
  • FIG. 10 shows one embodiment of an actuable release mechanism.
  • FIG. 10 shows an actuation device for accomplishing the release.
  • a closure member 80 (which can be any of the described closure members) contains, at its proximal end, a hook-shaped lip 82 .
  • FIG. 10 shows that, extending through elongate member 22 are a plurality of wires (or a sheath) which has mating hooks 84 . Hooks 84 are connected to a proximal actuator 86 mechanism by linkages 90 and 92 which can simply be wires.
  • Actuator 86 can be a trigger, a pull wire, a cylinder or any other desired actuable mechanism.
  • hooks 84 When actuator 86 is actuated, mating hooks 84 reciprocate generally in the direction indicated by arrows 94 . Thus, hooks 84 come out of engagement with lip 82 and thus release mechanism 80 .
  • closure hooks and backing can be formed with any desired, known materials.
  • they can simply be biocompatible hook and loop fabric, or they can be bioabsorbable hook and loop fabric as well or other materials.
  • they can be treated with any desired therapeutic agent to accomplish any desired effect, such as endothelial growth, drug release, antibiotics or any other desired therapeutic action.
  • hooks described herein can simply be hooks formed of conventional hook and loop fabric, they can also be formed of substantially rigid hooks with a sharpened, tissue piercing tip so that they can pierce tissue. In that embodiment, they can be used to close substantially any opening or traumatic wound in the skin.
  • the sharpened hooks are located on the initial proximal rings of hooks for use in areas where no, or very little, adventitia is found. This allows the hooks to pierce other tissue, such as the skin. Subsequent collapse of the hook and pile fabric on itself, and release of the device, again closes the wound.
  • Such a device can readily be used, for example, for emergency wound closure to close wounds quickly. During use, the device is simply inserted in the wound, and then withdrawn proximally. The sharpened hooks pierce and grab the skin, and the hook and pile collapses onto itself to form a closure, closing the wound.
  • hooks described herein are shown for purposes of clarity, as large hooks such as those used with conventional hook and loop fabric. However, they can of course be much smaller (such as microscopic) and formed of a wide variety of shapes, such as arrows, barbs, etc. Also, they could be randomly oriented and covered when inserted and exposed when withdrawn, so long as they are atraumic when traveling in the distal direction and engaging in the proximal direction.
  • the inventive aspects of the invention may be applied to virtually any anatomically required shape, including ovals, long strips or even a rolled up or other configuration.
  • the protruding hook and pile structure may be a uniform or non-uniform shape to match the required anatomy.
  • closure device discussed herein can accomplish closure of an opening in a vessel or body cavity by simply being inserted into the body cavity and then withdrawn in one smooth motion.
  • the hooks become firmly entangled in the adventitia and therefore form a quick and reliable closure located at precisely the point where closure is desired.

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  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
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  • Heart & Thoracic Surgery (AREA)
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US10/616,622 2003-07-10 2003-07-10 System for closing an opening in a body cavity Expired - Fee Related US7942897B2 (en)

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US10/616,622 US7942897B2 (en) 2003-07-10 2003-07-10 System for closing an opening in a body cavity
PCT/US2004/021972 WO2005006989A2 (fr) 2003-07-10 2004-07-09 Systeme d'obturation d'une ouverture dans une cavite corporelle

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US20100185140A1 (en) * 2006-06-30 2010-07-22 Kassab Ghassan S Devices, systems, and methods for promotion of infarct healing and reinforcement of border zone
US20100228221A1 (en) * 2006-06-30 2010-09-09 Kassab Ghassan S Devices, systems, and methods for obtaining biopsy tissue samples
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US20100312256A1 (en) * 2006-06-30 2010-12-09 Cvdevices, Llc Devices, systems, and methods for lead delivery
US20110144572A1 (en) * 2007-04-27 2011-06-16 Kassab Ghassan S Steering engagement catheter devices, systems, and methods
US20110224720A1 (en) * 2010-03-11 2011-09-15 Cvdevices, Llc Devices, systems, and methods for closing a hole in cardiac tissue
US8540674B2 (en) 2007-04-27 2013-09-24 Cvdevices, Llc Devices, systems, and methods for transeptal atrial puncture using an engagement catheter platform
US8740936B2 (en) 2010-09-13 2014-06-03 Boston Scientific Scimed, Inc. Pinch vascular closure apparatus and method
US9050064B2 (en) 2007-04-27 2015-06-09 Cvdevices, Llc Systems for engaging a bodily tissue and methods of using the same

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US9456811B2 (en) * 2005-08-24 2016-10-04 Abbott Vascular Inc. Vascular closure methods and apparatuses
US8920442B2 (en) * 2005-08-24 2014-12-30 Abbott Vascular Inc. Vascular opening edge eversion methods and apparatuses
US8758397B2 (en) * 2005-08-24 2014-06-24 Abbott Vascular Inc. Vascular closure methods and apparatuses
US20070060895A1 (en) * 2005-08-24 2007-03-15 Sibbitt Wilmer L Jr Vascular closure methods and apparatuses
US8617205B2 (en) 2007-02-01 2013-12-31 Cook Medical Technologies Llc Closure device
WO2008094706A2 (fr) * 2007-02-01 2008-08-07 Cook Incorporated Dispositif de fermeture et procédé de fermeture d'une ouverture corporelle
US9427217B2 (en) * 2007-02-05 2016-08-30 Boston Scientific Scimed Inc. Apparatus and method for closing an opening in a blood vessel using memory metal and collagen
US8292907B2 (en) * 2007-08-31 2012-10-23 Cook Medical Technologies Llc Balloon assisted occlusion device
US20090062839A1 (en) * 2007-08-31 2009-03-05 Cook Incorporated Barbed stent vascular occlusion device
US7875054B2 (en) * 2007-10-01 2011-01-25 Boston Scientific Scimed, Inc. Connective tissue closure device and method
MX2012006305A (es) * 2009-12-02 2012-12-17 Apica Cardiovascular Ireland Ltd Sistema y metodo de dispositivo para cierre de un sitio de acceso a tejido.
US8597340B2 (en) 2010-09-17 2013-12-03 Boston Scientific Scimed, Inc. Torque mechanism actuated bioabsorbable vascular closure device
WO2012051489A2 (fr) 2010-10-15 2012-04-19 Cook Medical Technologies Llc Dispositif d'occlusion destiné à bloquer l'écoulement des fluides dans des passages corporels
US9375208B2 (en) 2010-12-30 2016-06-28 Covidien Lp Wound closure device
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US9414822B2 (en) 2011-05-19 2016-08-16 Abbott Cardiovascular Systems, Inc. Tissue eversion apparatus and tissue closure device and methods for use thereof
US10940167B2 (en) 2012-02-10 2021-03-09 Cvdevices, Llc Methods and uses of biological tissues for various stent and other medical applications
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